医学
内科学
不良事件通用术语标准
不利影响
肺癌
肿瘤科
贝伐单抗
实体瘤疗效评价标准
癌症
化疗
免疫疗法
乙型肝炎
胃肠病学
进行性疾病
作者
Zhiting Zhao,Ran Hu,Yan Chen,Guoren Zhou,Shaorong Yu,Jifeng Feng
摘要
<b><i>Background:</i></b> Immune checkpoint inhibitors have become new research hot spots in the treatment of non-small-cell lung cancer (NSCLC), but the efficacy and safety of immunotherapy for patients with chronic infection are still unclear because existing clinical trials often exclude those patients. <b><i>Materials and Methods:</i></b> We identified 78 locally advanced or advanced NSCLC patients with chronic infection treated with programmed death-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitors alone or combined with the chemotherapy/bevacizumab therapy, of whom 60 with hepatitis B, 2 with hepatitis C, and 16 with syphilis. Objective response rates were assessed using the RECIST v1.1. Adverse events (AEs) were graded following the National Cancer Institute Common Terminology Criteria for Adverse Events v5.0. <b><i>Results:</i></b> Objective responses were observed in 19 out of 78 (24.36%) patients, and the disease control rate was 69.23% (54/78). No patient achieved a complete response. The median progression-free survival (PFS) was 6.49 months (95% CI: 3.71–9.27). PFS was 1.44 months (95% CI: 0.00–4.34) for monotherapy versus 7.34 months (95% CI: 4.50–10.18) for combination therapy (<i>p</i> = 0.053). Patients in the first-line treatment group revealed relatively higher ORR and longer PFS (ORR: 48.00% vs. 13.20%, <i>p</i> = 0.001; PFS: 7.67 vs. 5.57 months, <i>p</i> = 0.129). Patients with combined radiotherapy showed longer PFS than those without combined radiotherapy (14.07 vs. 4.62, <i>p</i> = 0.027). The incidence of AEs of any grade was 73.07% (57/78), among which there were 7 cases of grade 4 AEs. The incidence of leukopenia in any grade of AEs was the highest (57.69%), followed by anemia (25.64%), elevated alanine aminotransferase or aspartate aminotransferase (24.36%), and fatigue (21.79%). Hepatic transaminase increased in 26.7% (16/60) of HBV-infected patients and remained unchanged in 65.0% (39/60) patients. <b><i>Conclusions:</i></b> The PD-1 inhibitor showed an acceptable toxicity profile and moderate efficacy on NSCLC patients with chronic infection, but still has the potential to increase the incidence of hepatitis.
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